510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851675Substantially Equivalent

The Percutaneous Nephrostolithotomy Drape

Lingeman Medical Products, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851675 is the FDA 510(k) clearance record for THE PERCUTANEOUS NEPHROSTOLITHOTOMY DRAPE, a class II device, cleared for Lingeman Medical Products, Inc. on under FDA product code EYY (Drape, Urological, Disposable). FDA records list one 510(k) clearance for Lingeman Medical Products, Inc. As of , FDA records show no recalls naming K851675.

Clearance record

Decision date
Received
(21 days to decision)
Product code
EYY Drape, Urological, Disposable
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Lingeman Medical Products, Inc. 3401 Xenia Cir., Indianapolis IN
Third party review
No

Clearances, product code EYY

Trailing 12 months

FDA records hold no clearances under product code EYY in the trailing twelve months.

FDA records show no clearances under product code EYY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EYY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260